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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP110007
Date Received02/22/2011
Decision Date07/02/2012
Product Code LZP 
Docket Number 12M-0734
Notice Date 07/16/2012
Advisory Committee Ophthalmic
Clinical TrialsNCT00972621
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE HEALON ENDOCOAT OVD. HEALON ENDOCOAT OVD IS AN OPHTHALMIC VISCOELASTIC CONTAINING 3% SODIUM HYALURONATE INDICATED FOR USE AS A SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT SURGICAL PROCEDURES INCLUDING, CATARACT SURGERY WITH AN INTRAOCULAR LENS, CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS, AND SECONDARY INTRAOCULAR LENS IMPLANTATION. HEALON ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCEDURE AND PROTECTS THE CORNEAL ENDOTHELIUM AND OTHER OCULAR TISSUE. THE VISCOELASTICITY OF THE SOLUTION MAINTAINS THE NORMAL POSITION OF THE VITREOUS FACE AND PREVENTS FORMATION OF A FLAT CHAMBER DURING SURGERY. IT MAY ALSO BE USED TO COAT INTRAOCULAR LENSES AND INSERTION INSTRUMENTS PRIOR TO INTRAOCULAR LENS IMPLANTATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
S013 
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